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Psych Congress  

Major Depressive Disorder with Mixed Features: Clinical Characteristics of Patients Entered in a Multiregional Placebo-Controlled Study

Authors  
Jo Cara Pendergrass, PhD
Steven Targum, MD
Trisha Suppes, MD, PhD
Lee Sang
Robert Silva, PhD
Josephine Cucchiaro, PhD
Antony Loebel, MD
Sponsor  
Sponsored by Sunovion Pharmaceuticals Inc. Clinicaltrials.gov identifier: NCT01421134.

Objective: To identify the predominant manic symptoms at baseline in a multiregional, placebo-controlled study involving patients with major depressive disorder (MDD) with mixed features. Methods: RESOLVE 1 was a randomized, 6-week, double-blind, placebo-controlled study of lurasidone (once-daily, flexibly dosed 20-60 mg/d). Patients had a diagnosis of MDD, current major depressive episode, and 2-3 protocol-specified manic symptoms for ≥2 weeks. Results: Of 211 enrolled patients, 62 were from US sites and 149 were from Europe. Baseline mean (SD) MADRS score was 33.2 (4.2) with no significant difference in the United States compared to Europe. The MADRS items of apparent sadness, reported sadness, reduced sleep, and concentration difficulties were associated with the highest mean item scores at study baseline. Baseline mean (SD) Young Mania Rating Scale (YMRS) score was 12.4 (5.0) in the United States and 10.0 (4.1) in Europe (t=3.56; P=0.0004). Overall, the YMRS items of decreased need for sleep, increased rate or amount of speech (talkativeness), and irritability were associated with the highest item mean scores at study baseline. Of the 211 patients, 63.0% endorsed experiencing 2 of the 7 protocol-specific manic symptoms for ≥2 weeks prior to screening, whereas 37.0% endorsed 3 manic symptoms. Flight of ideas (racing thoughts) and increased talkativeness (pressured speech) were endorsed by >60% of patients. Discussion: We identified flight of ideas (racing thoughts) and increased talkativeness (pressured speech) as the most common manic symptoms meeting eligibility criteria in this acutely depressed population. In this analysis, irritability and distractibility (concentration difficulties) were also commonly reported.

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